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    The EU Clinical Trials Register currently displays   42516   clinical trials with a EudraCT protocol, of which   7000   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-003137-40
    Sponsor's Protocol Code Number:F02207GE302
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2005-003137-40
    A.3Full title of the trial
    A European Phase III, Multicentre, Double-blind, Randomised, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome.
    Estudio europeo, de fase III, multicéntrico, doble ciego, con asignación aleatoria y control con placebo, del milnacipran en monoterapia para el tratamiento del síndrome de la fibromialgia.
    A.4.1Sponsor's protocol code numberF02207GE302
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPierre Fabre Medicament
    B.1.3.4CountryFrance, Metropolitan
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMilnacipran hydrochloride 25 mg
    D.3.2Product code F02207
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMilnacipran hydrochloride
    D.3.9.2Current sponsor codeF02207
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMilnacipran hydrochloride 50 mg
    D.3.2Product code F02207
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMilnacipran hydrochloride
    D.3.9.2Current sponsor codeF02207
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fibromyalgia, also known as FMS, is a common systemic rheumatologic disorder estimated to affect 2 to 4% of the population [51, 50]. Fibromyalgia is associated with a reduced threshold for pain, generally identified by an increased sensitivity to pressure at particular points on the body, and is often accompanied by fatigue, sleep disturbance, and morning stiffness. Other common symptoms include headache, migraine, variable bowel habits, diffuse abdominal pain, and urinary frequency.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of milnacipran 200 mg/day as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of 200 mg/day of milnacipran to placebo on the time course and durability of response
    To compare the efficacy of 200 mg/day of milnacipran to placebo on a number of additional secondary endpoints including, but not limited to, fatigue, sleep and mood
    To establish the safety profile of 200 mg/day of milnacipran in patients with FMS.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Female and male patients aged 18 - 65 years with a diagnosis of fibromyalgia according to the 1990 ACR criteria.Females must be either postmenopausal (no menses for at least 1 year) or status-post hysterectomy, oophorectomy (bilateral), tubal ligation or, if of childbearing potential, must have a negative urine pregnancy test prior randomisation, and be using a medically acceptable form of contraception for about two months before the inclusion in this study (i.e., hormonal birth control, IUD, double barrier [male condom, female condom, diaphragm] or a barrier method plus a spermicidal agent [contraceptive foam, jelly, or cream]). The patient should be advised to continue the contraception one month after the intake of the last dose of study treatment.Patients must have the ability to give informed consent.Patients must be willing to withdraw from CNS-active therapies commonly used for FMS, including anti-depressants, anti-convulsants, mood stabilizers, opioids whatever the route of administration.Patients must be willing to discontinue treatment with transcutaneous electrical nerve stimulation, trigger point, tender point or joint injections, acupuncture, and anaesthetics (ketamine).Patients must be able to read and understand the text in local language on the Patient Electronic Diary (PED) screen.Patients must be able to hear and respond to the PED audible prompts.Patients must be willing and able to use a PED device daily for a minimum of 22 weeks and 2 days.Patients must not miss greater than 4 PED morning reports during the relevant days of the baseline period (the relevant days are defined as the 14 days prior to Visit 3 during the time interval between Visit 2 and Visit 3). The baseline period must be a minimum of 14 days.Patients must have an average VAS intensity pain scale recording (based on the electronic diary daily pain recall) of at least 40 or more on a 0-100 scale at the end of the baseline period. The baseline period must be a minimum of 14 days.
    E.4Principal exclusion criteria
    Severe psychiatric illness and significant risk of suicide. Patients suffering from a current major depressive episode (MDE-current), or a generalized anxiety disorder (GAD). Patients abusing of alcohol, benzodiazepines or other drugs, substances (cannabis) as defined by the MINI performed by trained staff. Patients with a positive urine drug screen for benzodiazepines and opiates will not be included.Any history or behavior that would, in the Investigator’s estimation, prohibit compliance for the duration of the study.Patients with myocardial infarction within the past 24 months, active cardiac disease (American Heart Association Functional Class 2, 3 or 4), congestive heart failure, hemodynamically significant valvular heart disease (including patients with a prosthetic heart valve), and/or clinically significant cardiac rhythm or conduction abnormalities and/or unstable or uncontrolled hypertension.Patients with pulmonary dysfunction or severe chronic obstructive pulmonary disease that, in the Investigator’s judgment, could interfere with the study participation and completion.Patients with evidence of active liver disease (levels of AST, ALT and/or alkaline phosphatase >1.5x the upper limit of the normal range for the laboratory performing the test).Patients with renal impairment (creatinine > 1.3x the upper limit of the normal range for the laboratory performing the test, adjusted for patient gender, age and lean body weight).Patients with documented systemic autoimmune disease.Chronic inflammatory rheumatoid disease.Patients with current systemic infection.Epileptic patients.Patients with active cancer, (except basal cell carcinoma), or patients currently undergoing therapy for cancer. Patients with a current life expectancy less than one year.Patients with sleep apnea severe enough that, in the Investigator‘s opinion, it would interfere with interpretation of changes in sleep habits. In addition, patients requiring use of CPAP devices are not eligible for the study.Patients with active peptic ulcer, inflammatory bowel disease.Patients with unstable endocrine disease, including unstable diabetes or thyroid disease. Disorders that have been stable under treatment for the preceding 3 months will be acceptable. Male patients with prostatic enlargement or other genito-urinary disorders, who might be at significant risk of dysuria and/or urinary retention when taking agents with noradrenaline re-uptake inhibition properties.Pregnant or breastfeeding females patients.Patients who have received treatment with an experimental agent within the last 30 days.Patients who are receiving concomitant therapy with MAO-A or -B inhibitors, tricyclics, tetracyclics, SSRIs agents, NARIs agents, SNRIs agents or alpha-agonists, anticonvulsants (phenytoin), dopamine agonists, or muscle relaxants.Patients who are receiving concomitant therapy with metabolic enzyme inhibitors (i.e., cimetidine) and enzyme inducers (including phenytoin and phenobarbital), oral anticoagulants (warfarin), type 1C antiarrhythmics (propafenone, flecainide, encainide).Patients who are receiving concomitant therapy with epinephrine, norepinephrine (alpha and beta sympathomimetics) especially when given by parenteral route.Statines if not stable for 4 weeks prior to the randomisation.Patients with concurrent usage of hypericum, SAMe, melatonine, or DHEA.Patients with concurrent usage of digitalis (digoxin) preparations.Patients with concurrent usage of centrally acting analgesics, including tramadol, codeine, dextropropoxyphene and other opioids or opiates.Patients with concurrent usage of systemic steroids by oral, IV or IM route.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Primary variables: Daily 24 h Recall Pain Score and Patient Global Impression of Change (PGIC).·
    Misc. status assessments: periodically, as described in the schedule of evaluations: Beck Depression Inventory BDI, State Trait Anxiety Inventory (STAI) sleep quality scale (MOS), and sexual dysfunction (ASEX).·
    FMS Status Assessments: Fibromyalgia Impact Questionnaire (FIQ total and FIQ subscores), Pain threshold, Pain drawing, Multiple Ability Self-report Questionnaire (MASQ, cognitive function), the Multidimensional Health Assessment Questionnaire (MDHAQ), the Multi-dimensional Fatigue Inventory (MFI), FS-36 PCS subscore (assessment of function over time), Patient Global Disease Status, Patient Global Therapeutic BenefitElectronic diary assessments include morning report pain (current and 24-hour recall,), evening report pain (current pain), overall pain last week (weekly report Friday evening), study medications taken (morning and evening report), concomitant treatment (evening report for the last 24 hours), overall fatigue VAS and sleep VAS in the last week (weekly report on Friday evening), PGIC and FIQ during on site visits.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The date of the last visit of the last patient undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-01. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
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